The impact of a nurse-led care programme on events and physical and psychosocial parameters in patients with heart failure with preserved ejection fraction: a randomized clinical trial in primary care in Russia

Abstract

Background: Disease management programmes (DMPs) improve quality of care for patients with heart failure (HF). However, only a limited number of trials have studied the efficacy of such programmes for patients with heart failure with preserved ejection fraction (HFPEF).

Objective: To estimate the impact of a structured, nurse-led patient education programme and care plan in general practice on outcome parameters and events in patients with HFPEF.

Methods: Single blinded randomized clinical trial with an intervention over six months and a follow-up during 12 additional months. In the control group, the patients (n = 41) were managed according to Russian national guidelines. Patients in the intervention group (n = 44) received education on individual lifestyle changes and modifications of cardiovascular disease (CVD) risk factors, home-based exercise training and weekly nurse consultations in addition to usual care.

Results: Six months after their inclusion, patients in the intervention group significantly improved body mass index, waist circumference, six-min walk test distance, total cholesterol, low-density lipoprotein, left ventricular end-diastolic volume index, quality of life and level of anxiety. After 18 months, there were 11 deaths (25%) or hospitalizations in the intervention group and 12 (29%) in the control group (P = 0.134). Cardiovascular mortality and readmission rate were not reduced significantly after six months of follow-up: the hazard ratio was 0.47 (95% CI: 0.17-1.28; P = 0.197). After 18 months, this was 0.85 (0.42-1.73; P = 0.658).

Conclusion: This primary care based DMP for patients with HFPEF improved the patients' emotional status and quality of life, positively influenced body weight, functional capacity and lipid profile, and attenuated heart remodelling.